N/A
N=396
Positive Psychology Intervention to Treat Diabetes Distress in Teens With Type 1 Diabetes
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03845465 ↗Enrolled (actual)
396
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Hemoglobin A1c — 9.0; 9.0 Percentage of glycated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Affect + Education (Behavioral); Education (Behavioral)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c |
9.0; 9.0 | — |
| SECONDARY Diabetes Distress |
43; 45 | — |
| SECONDARY Primary Control Coping |
.16; .16 | — |
| SECONDARY Secondary Control Coping |
.24; .23 | — |
| SECONDARY Disengagement Coping |
.16; .16 | — |
| SECONDARY Positive Affect |
41; 44 | — |
| SECONDARY Diabetes Self-Care Behavior |
3.74; 3.72 | — |
| SECONDARY Diabetes-Related Quality of Life |
52; 52 | — |
Summary
The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents experience diabetes distress related to the daily demands of diabetes care, which can cause problems with diabetes management and glycemic control. The proposed study will conduct a multisite, randomized trial to test the effects of a positive psychology intervention aimed at treating diabetes distress and improving glycemic outcomes. The potential benefits include helping adolescents achieve better glycemic control, improved self-management, and psychosocial outcomes
Eligibility Criteria
Inclusion Criteria
- Age 13-17
- Diagnosed with type 1 diabetes for at least 12 months
- Speak and read English
- Report at least moderate diabetes distress on the Problem Areas in Diabetes Scale - Teen version
Exclusion Criteria
- Other serious health conditions
Data sourced from ClinicalTrials.gov (NCT03845465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.